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Nalbuphine in ARDS Patients After Surgery

NCT06037330 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-13

No results posted yet for this study

Summary

Critically ill patients need reasonable and moderate analgesic and sedative treatment to eliminate or reduce pain, anxiety and restlessness, improve patient comfort and cooperation, reduce patients' stress response, protect organ function and optimize prognosis. As a semi-synthetic opioid receptor agonist-antagonist, nalbuphine can bind to μ, κand δ receptors, has partial antagonistic effect on μ receptor, and is fully activated on κreceptor, with very weak δ receptor activity. Results of a study on the efficacy and safety of nalbuphine for analgesia in ICU patients showed that nalbuphine has sustained and stable analgesic effect for patients with mild to moderate analgesic needs in ICU, the onset time is comparable to sufentanil, and excessive sedation caused by sufentanil can be avoided, and the effect on hemodynamics is small. It can be used as a new choice of analgesic drugs in ICU.

A single-center, randomized, single-blind, prospective study was designed to compare nalbuphine and sufentanil in patients with ARDS after surgery. Sixty patients with ARDS after surgery to be admitted to ICU were randomly divided into experimental group (Nalbuphine group) and control group (Sufentanil group). This study aims to determine the analgesic efficacy and safety of nalbuphine hydrochloride in patients with Acute Respiratory distress syndrome (ARDS) after surgery. The successful development of this study will provide more theoretical basis for the individualized analgesic sedation program for surgical patients.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

DRUG

Nalbuphine

Nalbuphine was injected intravenously. The target CPOT score was \<2, and the target RASS score was -2 \~ 1. 40 mg of nalbuphine was diluted into 50 mL solution, the load was 0.1mg/kg, the maintenance dose was 0.04-0.08mg/kg/h, the CPOT score was \<2, and the maximum daily dose was 160mg.

DRUG

Sufentanil

Sufentanil was injected intravenously, and the target CPOT score was \<2, and the target RASS score was -2 \~ 1. 0.1mg of sufentanil was diluted into 50 mL solution, the loading dose was 0.2-0.5μg/kg, the maintenance dose was 0.2-0.3μg/kg/h, and the CPOT score was \<2 points

Sponsors & Collaborators

  • Hairong Chen

    lead OTHER

Principal Investigators

  • Hairong Chen, doctor · Qianfo Mountain Hospital, Shandong Province

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2026-04-28
Completion
2026-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06037330 on ClinicalTrials.gov